York Study of Unloading Shoes for Vascular Intermittent Claudication
Intermittent ClaudicationPeripheral Arterial DiseaseSome people experience a cramp-like leg pain during walking that is relieved only by rest. This is called intermittent claudication (IC) and it is a common symptom of peripheral arterial disease. Patients with IC struggle to walk, which in turn lowers their quality of life. The intensity of IC pain experienced during walking depends on several factors, including the type of footwear worn. For example, non-supportive shoes may make the calf muscles work harder during walking, leading to earlier and more-severe symptoms of IC. A member of the research team has developed a shoe that reduces the work done by the lower-leg muscles during walking. Preliminary data indicate that, when wearing these "unloading shoes", people with IC were able to walk further without pain as compared with when wearing a normal pair of shoes. The current project aims to provide further information on the usefulness and acceptability of these shoes. Forty people with IC will complete a set of three walking tests on two separate occasions; once whilst wearing the unloading shoes, and once whilst wearing some normal shoes. The participants will then be given a pair of unloading or normal shoes to wear for two weeks, after which we will collect information on how acceptable the shoes were to wear via a survey of all participants and one-to-one interviews with a subset of participants.
Cost-utility Analysis of the Outpatient Versus Conventional Hospitalization in Treatment of Occlusive...
Peripheral Arterial DiseaseThe purpose of this study is to assess the efficiency of outpatient surgery compared to conventional hospitalization in endovascular treatment of occlusive arterial disease. A cost-utility analysis will be conducted from a societal perspective. Patients referred for peripheral arterial disease (PAD) will be randomized in two arms and a 3 months follow-up will be performed.
Ultrasound to Enhance Paclitaxel Uptake in Critical Limb Ischemia: the PACUS Trial
Peripheral Arterial DiseaseAngioplastyThe PACUS Trial was a single center, single blinded, randomized trial designed to evaluate the safety and efficacy of intravascular percutaneous catheter-delivered ultrasound energy to improve local Paclitaxel delivery effects in critical limb ischemia patients due to femoral-popliteal artery disease.
A Single-dose Escalation Safety and PK Study for PLC in Healthy Chinese
Peripheral Arterial DiseaseThe main objective is to evaluate the effect of single dose Propionyl-L-Carnitine Hydrochloride on clinical pharmacokinetic characteristics and its effect of clinical pharmacokinetic characteristics and safety on healthy Chinese subjects to provide a basis for market authorization registration.
Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter
Peripheral Arterial DiseasePeripheral Vascular Diseases1 moreThe objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB PTA Catheter in a heterogeneous patient population in a real world and on-label clinical application.
Intensive Rehabilitation in Peripheral Arterial Disease With Claudication: Effects of a Treadmill...
Peripheral Arterial DiseaseClaudicationRehabilitation is the first intention treatment of peripheral arterial disease (PAD) with claudication. Initially proposed in the sixty's, rehabilitation programs dedicated to patients with PAD have recently been proved effective and defined in many guidelines. Supervised walking training on treadmill is recommended. Usually patients walk up to a mild or moderate pain (evaluated at 3 or 4 on the claudication pain scale; maximum pain =5), then stop until pain completely subsides and walk again . The Artex study assesses the efficacy of a fractionated mode of training avoiding pain by alternating short sequences of intensive training and active recovery (without rest).
Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent
Peripheral Arterial DiseasesSuperficial Femoral Artery StenosisThe intent of this clinical registry is to demonstrate the efficacy of the EPIC™ stent in patients with superficial femoral/ popliteal artery disease. 100 patients with symptomatic femoropopliteal artery lesion will be enrolled in the study and shall undergo 4 visits during the trial -a pre-procedure visit, procedure visit at which time the stent will be placed, and follow-up visits at 6 and 12 months. Study hypothesis: The EPIC™ Self-Expanding Nitinol Vascular Stent with Delivery System will be efficacious in patients with Superficial Femoro/Popliteal Artery disease.
Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar...
Peripheral Artery DiseasePeripheral Vascular DiseaseThe objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.
EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study
Peripheral Arterial DiseasesThe purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system.
A Phase IIB Pilot Study of a Modified Dosage Regimen of AMG0001 in Subjects With Critical Limb Ischemia...
Critical Limb IschemiaVascular Diseases1 moreThe purpose of the study is to confirm the feasibility of study procedures and the tolerability of a new dose regimen of AMG0001 in subjects with Critical Limb Ischemia (CLI)